Be highly skeptical of anything released before the end of the year
The clinical trials for the COVID-19 vaccine are happening with unprecedented speed — which is good. To get there, Schaffner said, the vaccines are being built on existing technology, scientists are working around the clock, and the vaccines are going through clinical trials at the same time the companies are ramping up production — that way, everything will be ready to go as soon as a vaccine gets the green light. Schaffner said it’s also likely that the FDA will approve the new vaccine under a faster process called an Emergency Use Authorization, rather than under the slower standard licensure system.
But there is such a thing as too speedy. Topol, who has worked on large clinical trials for nearly three decades, didn’t mince words: It would be impossible to have a properly vetted COVID-19 vaccine ready for public release before the general election — at least one that’s had any kind of real safety and efficacy testing. “Capital ‘i’ impossible,” he said. That’s because a trial can move only so fast. The most promising trials are still enrolling participants, and they have to wait two to four weeks between taking each of the two doses of the vaccine. By the time they finish enrolling people, you’re almost at the end of October, Topol said, and then you still have to give the trial time to see whether the vaccine even works. If the trials end too early, it’s easy to end up with a vaccine that’s much less effective than you think it is. February, or even January, would be a much more realistic time frame to get a vaccine that has met basic standards of trustworthiness, he said.